KaVo ORTHOPANTOMOGRAPH OP 3D User And Installation Manual
  1. Manuals
  2. Brands
  3. KaVo Manuals
  4. Medical Equipment
  5. ORTHOPANTOMOGRAPH OP 3D
  6. User and installation manual

KaVo ORTHOPANTOMOGRAPH OP 3D User And Installation Manual

Orthopantomograph
Hide thumbs Also See for ORTHOPANTOMOGRAPH OP 3D:
Table of Contents

Advertisement

Quick Links

See also: Service Manual , Installer and User Manual
ORTHOPANTOMOGRAPH
User and Installation manual
ENGLISH
212972 rev. 6
0.805.4913
™
OP 3D

Advertisement

Table of Contents
loading

Related Manuals for KaVo ORTHOPANTOMOGRAPH OP 3D

Summary of Contents for KaVo ORTHOPANTOMOGRAPH OP 3D

  • Page 1 ORTHOPANTOMOGRAPH ™ OP 3D User and Installation manual ENGLISH 212972 rev. 6 0.805.4913...

  • Page 3: Table Of Contents

    Contents 1 Disclaimer..............6 2 Introduction..............7 ™ 2.1 ORTHOPANTOMOGRAPH OP 3D.............. 7 2.2 Intended use..................7 2.3 Intended user profile................7 2.4 Associated documentation............... 7 2.5 Abbreviations..................8 2.6 Signal words..................8 2.7 Disposal and recycling................8 2.8 Warnings and requirements..............9 2.8.1 Warnings and precautions for use..........9 2.8.2 Warnings and precautions for installation........9 2.8.3 Connection requirements............
  • Page 4 6.5.2 Taking Scout and 3D images............41 7 Maintenance.............. 43 7.1 Cleaning and decontamination..............43 7.2 Quality Control..................44 7.2.1 PAN QC..................44 7.2.2 3D QC..................45 7.3 Calibrations for the user................ 48 7.3.1 When to calibrate the device............48 7.3.2 Preparation for Calibration............48 7.3.3 Calibration procedure..............
  • Page 5 10.2 Imaging program specifications............102 10.3 Patient contacting parts..............104 10.4 Device dimensions................105 10.5 Symbols that may appear on the device or its parts......108 10.6 Electromagnetic Compatibility (EMC) tables.......... 110 10.7 X-ray tube assemblies............... 114 10.8 Minimum workstation requirements............. 116 ™...

  • Page 6: Disclaimer

    ™ ORTHOfocus and Low Dose Technology are either registered trademarks or trademarks of KaVo Kerr Group Finland in the United States and/or other countries. ™ KaVo is either registered trademark or trademark of Kaltenbach & Voigt GmbH in the United States and/or other countries.

  • Page 7: Introduction

    2 Introduction 2 Introduction ™ 2.1 ORTHOPANTOMOGRAPH OP 3D ™ The ORTHOPANTOMOGRAPH OP 3D (later called device) is a dental X-ray device producing high quality digital images of dentition, TM-joints and skull. To take images, you need a suitable workstation connected to the device and a dental imaging software to capture and manage the images.

  • Page 8: Abbreviations

    2 Introduction 2.5 Abbreviations Three dimensional ALARA As Low As Reasonably Achievable CBCT Cone Beam Computed Tomography Diameter Dose Area Product Frankfort-Horizontal Field Of View. The cylindrical 3D volume that is reconstructed by the device. Graphical User Interface Height ™ Low Dose Technology Metal Artifact Reduction.

  • Page 9: Warnings And Requirements

    2 Introduction • All electronic circuits and electronic boards • Plastic parts 2.8 Warnings and requirements 2.8.1 Warnings and precautions for use • Before using the device for the first time, familiarize yourself with this manual to ensure the safe use of the device. •...

  • Page 10: Connection Requirements

    2 Introduction • To avoid the risk of electric shock, the device must only be connected to a mains power outlet with protective earth. • The device shall not be connected to an extension cord. • Ensure the proper tightness and attachment of all of the screws and bolts when installing the device.

  • Page 11: Overview

    3 Overview 3 Overview 3.1 Main parts 1. Column 2. Carriage 3. Upper shelf 4. Rotating unit 5. Sensor 6. Tubehead 7. Power switch (Back of the device) 8. Exposure switch 9. Positioning panel 10. Emergency stop switch 11. Patient handles 12.

  • Page 12: Patient Positioning Lights

    3 Overview 3.2 Patient positioning lights NOTICE! Appropriate lights are turned on automatically, based on the selected modality, program and FOV. 3.2.1 Positioning light locations A. Tilt light (Panoramic image layer) B. Midsagittal light C. Horizontal light, top of FOV / FH light D.

  • Page 13: Lights

    3 Overview 3.2.3 3D lights B. Midsagittal light C. Horizontal light, top of FOV D. Horizontal light, bottom of FOV 3.3 Accessories Chin Rest Bite Block Lip Support (3D, TMJ and edentulous patients) Head Support with a detachable strap Disposable covers for patient positioning devices: •...

  • Page 14: Other Detachable Parts

    3 Overview 3.4 Other detachable parts CALIBRATION TOOLS: 3D Geometry Calibration Phantom 3D QC Phantom & 3D QC phantom holder QUALITY CONTROL TOOLS (OPTIONAL): 2D QC Test Phantom & Copper filter - 0.8 mm/1.8 mm PAN QC phantom holder ™ ORTHOPANTOMOGRAPH OP 3D...

  • Page 15: Emergency Stop Switch

    3 Overview 3.5 Emergency stop switch An emergency stop switch is located on the left side of the carriage. Pressing the emergency stop switch immediately terminates the imaging and all device movements. NOTICE! An interrupted imaging process cannot be resumed. A new image needs to be taken.

  • Page 16: User Interfaces

    4 User Interfaces 4 User Interfaces 4.1 Graphical User Interface (GUI) 4.1.1 GUI Overview 1. Selected patient name and Patient Identification (ID). 2. Selection of imaging modality, PAN or 3D. 3. Imaging program settings. 4. Main view area. Shows a dental chart for the selected modality and previews of the taken images.
  • Page 17 4 User Interfaces IMAGING PROGRAM SETTINGS: Test mode Indicates if Test mode is active. Press Test mode icon to disable/enable device radiation production. This mode can be used for example to demonstrate the device movements. You can also use the positioning panel to activate the Test mode. Patient size Indicates the currently selected patient size preset.

  • Page 18: Panoramic View

    4 User Interfaces 4.1.2 Panoramic view Panoramic imaging program selection ™ ORTHOselect panoramic dental chart Dental chart shows which segments of the dentition are imaged with the selected imaging program. You can also manually select which segments of the dentition are imaged.
  • Page 19 4 User Interfaces ™ QUICKcompose panoramic image preview NOTICE! Panoramic image previews are not shown in full resolution on GUI. Zoom slider You can zoom the preview image in/out using the zoom slider. While zoomed in, you can click and drag to scroll the image. Brightness slider You can adjust the brightness of the shown preview image using the brightness slider.

  • Page 20: View

    4 User Interfaces 4.1.3 3D view 3D imaging program selection ™ ORTHOselect dental chart Dental chart is used to select the Region of Interest (ROI) for the 3D scan. The FOV changes automatically according to the selections. Press teeth, jaw and TMJ icons to select which parts of the dentition are studied: •...
  • Page 21 4 User Interfaces FOV size Indicates the currently selected FOV size (H x D). Press the FOV size icon to open a list of the available 3D FOV sizes; 5 x 5, 6 x 9, 9 x 11 and 9 x 14 (optional). Press on the listed FOV size icon to activate it.
  • Page 22 4 User Interfaces ™ SMARTVIEW 2.0 scout image view FOV height adjustment You can adjust the height of the FOV, according the scout image, by sliding the height adjustment icon up or down. It's recommended to adjust the FOV size so that the ROI is in the middle of the volume.
  • Page 23 4 User Interfaces OK button Press OK button to approve the changes made to the FOV location and size using the Scout image and to proceed to the 3D exposure. ™ QUICKcompose 3D image preview NOTICE! 3D image previews are not shown in full resolution on GUI. NOTICE! The image has indications from which direction the image is shown;...
  • Page 24 4 User Interfaces Contrast slider You can adjust the contrast of the shown preview image using the contrast slider. NOTICE! Adjustment is not saved to the image. OK button Press OK button to close the image preview. ™ ORTHOPANTOMOGRAPH OP 3D...

  • Page 25: Settings Menu

    4 User Interfaces 4.1.4 Settings menu 1. CALIBRATIONS Shows a list of user performable device calibrations, their completion status and last completion date. The calibrations are performed through this menu. See chapters Calibrations for the user Complete device calibration for more detailed information on calibration programs and how to perform them.
  • Page 26 4 User Interfaces 3. SYSTEM INFO Software Show the device serial number and firmware versions. versions Notices Legal information and terms and conditions for use. Exposure Show amount of exposures taken with the device. counters 4. PREFERENCES Configurations Friendly name Set a name for the device, which is shown next to the settings icon and on the imaging software.
  • Page 27 4 User Interfaces Patient Size Adjust the default mA and kV values for imaging programs. Configuration 5. SERVICE MENU NOTICE! This menu is intended for authorized service personnel only. The Service menu can be accessed only with a PIN code. The Service menu contains: •...

  • Page 28: Positioning Panel

    4 User Interfaces 4.2 Positioning panel 1. Carriage up/down slider. The carriage can be driven up and down by sliding a finger on the carriage up/down slider. The speed of the carriage movement depends on the distance the finger is moved. 2.

  • Page 29: Imaging Programs

    5 Imaging programs 5 Imaging programs 5.1 Panoramic programs Standard Panoramic imaging program The Standard Panoramic imaging program provides general view of dental and facial anatomy based on panoramic imaging technique. You can choose which segments of the dentition are imaged if imaging of the whole dentition is not required.
  • Page 30 5 Imaging programs Bitewing program A bitewing view of the patient's Premolar-Molar region dentition. NOTICE! The segment widths and height differences shown here are for illustrative purposes only. TMJ, lateral projection Lateral TMJ program provides a lateral view of the patient's left and right temporomandibular joints.

  • Page 31: Programs

    5 Imaging programs 5.2 3D programs Always select the smallest feasible FOV size, resolution and imaging parameters for the 3D image in order to follow the ALARA (As Low As Reasonably Achievable) principle. NOTICE! It is always up to the dental professional to select the appropriate FOV, resolution and imaging parameters.

  • Page 32: Resolutions

    5 Imaging programs FOV 9 x 11 Optimized for imaging the entire dentition, both mandibula and maxilla, maxillary sinuses, jaws with bilateral joints and jaws with airways. Available resolutions: High resolution Standard resolution LDT resolution FOV 9 x 14 (optional) Optimized for imaging the entire dentition, both mandibula and maxilla, including airway and upper cervical spine or the sinus, maxillary sinuses, jaws with bilateral joints, jaws with airways, analyses of both TMJs and for...

  • Page 33: Using The Device

    6 Using the device 6 Using the device 6.1 General imaging workflow Select imaging Prepare the Power device on program workstation and initialize Place positioning Select patient size to accessories and position set imaging parameters patient to the device 95 kV 8.00 mA Release patient and end study...

  • Page 34: Powering On The Device

    6 Using the device 6.2 Powering on the device 1. Power the device on. Power switch is located at the rear of the carriage. 2. The device starts initialization. 3. Complete the device initialization by pressing the HOME button on the positioning panel when indicator light starts blinking in blue.

  • Page 35: Patient Positioning

    6 Using the device 6. GUI: Select or ensure the correct settings; imaging modality, imaging program and patient size. If the preset selections are not suitable for the patient, adjust the imaging parameters manually. Imaging Modality Imaging Program Patient size Imaging parameters 6.4 Patient positioning...
  • Page 36 6 Using the device 4. Select the patient positioning accessory according to the image to be taken, attach it to the chin rest and place them on the lower shelf of the device, as shown below. Panoramic Imaging: Standard and Pediatric Standard and Pediatric TMJ imaging panoramic and...
  • Page 37 6 Using the device 7. Open the head support locking lever on the lower shelf and push the head support towards the mirror. 8. Guide the patient to the device and instruct to stand as straight and as tall as possible.
  • Page 38 6 Using the device 11. Fine adjust the device's height and adjust patient's head position/orientation using the patient positioning lights as guides. NOTICE! To ensure optimal image quality, pay attention to the correct patient positioning. NOTICE! You can open the mirror and use it to help in positioning the patient.
  • Page 39 6 Using the device 3D IMAGING: • The patient's occlusal plane should be horizontal and the ROI is between the top and bottom FOV lights. NOTICE! You may place a cotton roll or similar between the patient's front teeth to separate the jaws. 12.

  • Page 40: Taking An Image

    6 Using the device 15. If you take a 3D image, place the head support strap behind patient's head and tighten it to minimize the patient movement. 6.5 Taking an image NOTICE! If the patient is feeling insecure or has an exceptional anatomy, use the Test mode to demonstrate the unit movements and to make sure that the rotating unit does not collide with the patient during the imaging process.

  • Page 41: Taking Scout And 3D Images

    6 Using the device 10. Continue to take the next image, if multiple images need to be taken. 11. Press "End Study" to end the study or return to imaging program. 12. Remove all disposable covers and decontaminate the device and the patient positioning accessories.
  • Page 42 6 Using the device 14. Release the patient from the device. 15. Image preview appears on the GUI for a quick review (no visible artifacts etc.). 16. Acknowledge the preview by pressing the OK button. 17. Continue to take the next image, if multiple images need to be taken. 18.

  • Page 43: Maintenance

    7 Maintenance 7 Maintenance The maintenance and calibration procedure intervals described here are minimum requirements and can be made more frequent and stringent to comply with local regulations regarding the use and maintenance of dental X-ray devices. 7.1 Cleaning and decontamination The device should be cleaned after every use.

  • Page 44: Quality Control

    7 Maintenance 7.2 Quality Control The Quality Control (QC) programs in the Quality Control menu are used to ensure that the image quality remains constant. Quality Control should be performed at regular intervals, preferably at least once a month and always after calibration. NOTICE! The device will automatically remind of retaking the QC images.
  • Page 45 7 Maintenance 6. Protect yourself from radiation. 7. Press and hold down the exposure switch to take the QC image. 8. The QC image preview appears on the GUI. 9. Acknowledge the result by pressing the OK button on the GUI. 10.
  • Page 46 7 Maintenance 2. GUI: Select Quality Control menu. 3. GUI: Select 3D QC program from the list. 4. Attach the 3D QC phantom holder and the 3D QC phantom to the device. 5. Protect yourself from radiation. 6. Press and hold down the exposure switch to take the QC image. 7.
  • Page 47 7 Maintenance 11. If the image fails or any visual defects are apparent, redo the QC program. If it fails again, recalibrate the device or contact service. ™ ORTHOPANTOMOGRAPH OP 3D...

  • Page 48: Calibrations For The User

    7 Maintenance 7.3 Calibrations for the user 7.3.1 When to calibrate the device The device must be calibrated and, if necessary, adjusted at regular intervals in accordance with the national regulations regarding the use, maintenance and service of dental X-ray devices. NOTICE! The device has multiple calibration programs, but only the ones listed in this chapter are meant to be performed by the user.
  • Page 49 7 Maintenance 2. A list of available device calibrations is shown with the status of the calibration. Calibration status indications: Calibration not performed Recalibration is required. Calibration performed or failed. successfully. 3. Start a calibration program by pressing the calibration name and follow the instructions on the GUI.

  • Page 50: Calibration Procedure

    7 Maintenance 7.3.3 Calibration procedure Perform the calibrations in the exact order instructed in here. 3D Pixel Calibration This program calibrates the sensor for 3D imaging. No calibration tools are required when performing this calibration. NOTICE! This calibration produces X-rays. Protect yourself from radiation. 1.
  • Page 51 7 Maintenance 4. When the exposure warning stops and the program end tone is played, the program is complete. 5. The calibration image appears on the GUI. 6. Acknowledge the calibration result by pressing the OK button. 3D Geometry Calibrations These programs create the calibration data for reconstructing 3D images.

  • Page 52: Annual Maintenance

    7 Maintenance 6. Acknowledge the calibration by pressing the OK button. 7. Repeat the calibration for the remaining FOV sizes. 7.4 Annual maintenance An authorized service technician must carry out a full inspection of the device once a year. The following checks must be carried out during the inspection: •...

  • Page 53: Troubleshooting

    8 Troubleshooting 8 Troubleshooting Problem Possible cause Solution Taken image is not Local network connection The device stores the latest transferred to the modality is disrupted, which causes image until a confirmation workstation. loss of data. of a succesfull transfer to the workstation has been received.

  • Page 54: Installation

    9 Installation 9 Installation NOTICE! This section of the manual is only for authorized service technicians. 9.1 Device package Package contents 1. Carriage and rotating unit. 2. Column and wall bracket. 3. Device covers. 4. Installation accessories, manuals and parts for device installation. 5.

  • Page 55: Space Requirements

    9 Installation • Do not install the device in environments where corrosive or explosive vapours or flammable anaesthics are present. • Special steps regarding EMC need to be taken when installing the device. For more information, refer to the chapter Electromagnetic Compatibility (EMC) tables.

  • Page 56: Fixing Hardware And Tools

    9 Installation Minimum operating space requirements Depth Minimum: min. 715 mm / 28.1 in min. 660 mm / 26 in 1385 mm / 54.5 in rec. 950 mm / 37.4 in Recommended minimum: 1630 mm / 64.2 in Width Minimum: 1375 mm / 54 in Recommended minimum:...

  • Page 57: Back Panel Connectors

    9 Installation 9.3 Back panel connectors 1. Power cord 2. Ethernet cable for workstation connection 3. Exposure button connector 4. Remote exposure switch connector (optional) 5. External warning light connector (optional) 6. Main fuses F1+F2 (10A fuses installed as default) 7.
  • Page 58 9 Installation 5. Open the lowest box to find the device column and the wall bracket. 6. Lift and set the column standing to the installation location. NOTICE! Use spirit level to ensure that the wall and floor of the chosen installation location are straight enough to allow the device to be installed vertically straight.
  • Page 59 9 Installation 9. Attach the wall side bracket to the column side bracket using the same bolts, washers and locking nuts that were previously detached. Do not tighten the bolts fully yet. 10. Adjust the angle and the depth of the wall bracket and tighten the angle adjustment screws (2 pcs) to lock the wall bracket into the desired position.
  • Page 60 9 Installation 15. Attach the column to the floor using appropriate screws and washers. NOTICE! Ensure that the column is vertically straight before fully tightening the floor screws. 16. Remove the bubble wrap between the outer and inner column covers. Ensure that the outer column cover plate is properly in place and doesn't scratch the inner column cover.
  • Page 61 9 Installation 20. Pull the protective plastic aside from the carriage to reveal the base plate and back panel connectors. 21. Check that the device's mains power configuration is applicable to the installation location. NOTICE! The device is delivered with 10A fuses installed. If installing to other than 230V mains voltage the fuses need to be changed.
  • Page 62 9 Installation 25. Lift the carriage onto the column using the installation rail as a hinge and by lifting from the cutouts in the plywood support. NOTICE! The liftable weight corresponds to approximately 55 kg and lifting it on the column may require two persons. NOTICE! Ensure that nothing gets caught between the carriage and the column.
  • Page 63 9 Installation 28. Detach the upper and rear screws (4 pcs) of the plywood cover on the other side and carefully pull it off with the metal supports attached. NOTICE! Hold the plywood cover in place when detaching the last screw to prevent it from falling down.
  • Page 64 9 Installation 32. Detach the two screws holding the front support bar in place, push it inside the upper shelf frame and reattach it. 33. Detach the linear movement support from the top shelf (2 screws). 34. Detach the rotating unit support from the carriage (4 screws), push the rotating unit outwards a bit and lift the support off from the rotating unit .

  • Page 65: Attaching The Covers

    9 Installation 36. Connect the Mains cable (1), Ethernet cable (2) and Exposure button cable (3) to the rear of the carriage. NOTICE! Route the Ethernet cable and exposure button cable through the strain relief. NOTICE! You can also connect other additional cables to the carriage at this point.
  • Page 66 9 Installation 3. Attach the right carriage side cover. Insert the claws on the cover into the slots on the rear of the column and turn the cover to correct position. Secure the cover in place with one screw under the status indicator light. 4.
  • Page 67 9 Installation 7. Attach the mirror by guiding the pins on the carriage plate (4pcs) through the keyholes on the mirror plate and sliding the mirror down to lock it in place. 8. Route the mains cord, exposure button cable, Ethernet cable and other optional cables through the cable clamp on the rear of the device.
  • Page 68 9 Installation 10. Attach the carriage back plate by pressing the hooks on the lower side of the plate to the gaps in the column and turning the upper side in place. 11. Attach the filler strips over the gaps under the carriage back plate. 12.
  • Page 69 9 Installation 14. Install the head support to the lower shelf by screwing the rods in. Slide the head support into the rods. 15. Attach the exposure button holder to the column or other metallic surface using its built in magnets or screw it to a non-magnetic surface. 16.

  • Page 70: Configuring The Communication Link To The Workstation

    9 Installation 9.6 Configuring the communication link to the workstation 1. Install the Dental Imaging software to the workstation. 2. Connect the device to the local area network (LAN) or directly to the workstation with an Ethernet cable. See chapter Connection options for more detailed information.
  • Page 71 9 Installation example 192.168.1.1 for the PC and 192.168.1.2 for the device. The recommended Subnet mask is 255.255.255.0. A static IP address can be configured to the device through the device driver. See software documentation for more information on how to configure the imaging software for device connection required for the static IP address configuration.

  • Page 72: Finishing The Installation

    9 Installation 9.7 Finishing the installation After the device has been installed, perform these checks and tasks, before handing it to the user. 1. Check the wall mount screw tightness. 2. Check the floor screw tightness. 3. Ensure that the wall mount screws match the wall material. 4.

  • Page 73: Complete Device Calibration

    9 Installation 9.8 Complete device calibration After the installation of the device and during the annual maintenance, a complete calibration procedure must be performed. See chapter Preparation for Calibration information on the unit calibration. Perform the calibrations in the order as described in this chapter. After the calibrations have been completed, the QC images need to be taken and stored for the user as reference.

  • Page 74: Device Movement Calibration

    9 Installation 9.8.2 Device Movement Calibration This program is used to calibrate the movements of the upper shelf and the rotating unit. No calibration tools are required when performing this calibration. 1. Select Device Movement Calibration from the Calibrations menu. 2.

  • Page 75: X-Ray Generator Calibration

    9 Installation 9.8.4 X-Ray Generator Calibration NOTICE! This calibration is pre-performed at the factory, but should be performed nonetheless. NOTICE! This calibration produces X-rays. Protect yourself from radiation. 1. Select X-Ray Generator Calibration from the Calibrations menu. 2. Protect yourself from radiation. 3.

  • Page 76: Device Geometry Calibration

    9 Installation 6. Acknowledge the calibration result by pressing the OK button. 9.8.6 Device Geometry Calibration NOTICE! This calibration produces X-rays. Protect yourself from radiation. NOTICE! This calibration is iterative and may need to be run a couple of times before it passes.

  • Page 77: Collimator Calibration

    9 Installation 9.8.7 Collimator Calibration No calibration tools are required when performing this calibration. NOTICE! This calibration produces X-rays. Protect yourself from radiation. NOTICE! The X-ray beam size is verified during this calibration. 1. Select Collimator Calibration from the Calibrations menu. 2.

  • Page 78: Geometry Calibrations

    9 Installation 3. Press and hold down the exposure button to take the calibration image. 4. When the exposure warning stops and the program end tone is played, the program is complete. 5. The calibration image appears on the GUI. 6.

  • Page 79: Pan Qc (Optional)

    9 Installation 4. Press and hold down the exposure button to take the calibration image. 5. The calibration results appear on the GUI. NOTICE! This will take several minutes. 6. Acknowledge the calibration by pressing the OK button. 7. Repeat the calibration for the remaining FOV sizes. 9.8.10 PAN QC (optional) NOTICE! The PAN QC is an optional, yet recommendable, procedure and is mandatory to be performed where local regulations require it.
  • Page 80 9 Installation 5. Attach the copper filter in front of the radiation window on the tube head. The filter attaches in place with magnets. 6. Protect yourself from radiation. 7. Press and hold down the exposure switch to take the QC image. 8.
  • Page 81 9 Installation 12. Save the passed QC image as a reference image for the user and let the user know the reference image location. 9.8.11 3D QC NOTICE! The device's country selection needs to be configured per local requirements before performing the QC programs. See chapter Device configuration.
  • Page 82 9 Installation 9. The QC image appears on the workstation, showing the result of the check. 10. Workstation: Visually evaluate the image using the dental imaging software for visual defects such as artifacts. NOTICE! The device determines if the QC image is PASSED or FAILED according to measured data, not based on the visible image quality.

  • Page 83: Panoramic Beam Size Verification (Optional)

    9 Installation 9.8.12 Panoramic beam size verification (optional) This program runs an automatic test to verify, that the X-ray beam hits the active area of the sensor with the required accuracy. NOTICE! The Panoramic Beam Size Verification is an optional, yet recommendable, procedure and is mandatory to be performed where local regulations require it.

  • Page 84: Additional Installation Procedures

    9 Installation 9.9 Additional installation procedures 9.9.1 Remote exposure switch installation A wall-mountable remote exposure switch, with integrated exposure warning light, is available as an option for the device. 1. Exposure switch 2. Exposure warning light 3. Exposure button connector If a remote exposure switch needs to be used, install it as follows: 1.

  • Page 85: Mains Power Configuration

    9 Installation 9.9.2 Mains power configuration Detach the indicated screw on the back panel cover and lift it off to access the device back panel. Mains connection type configuration IEC 60601-2-63 standard requires extraoral X-ray devices to be installed permanently. The device can, however, be installed with plug connection if the local regulations allow this.

  • Page 86: Changing The Fuses

    9 Installation If the device mains voltage needs to be changed, change the fuses accordingly. See chapter Changing the fuses for information on how to install the fuses. 9.9.3 Changing the fuses Main fuses are located at the rear of the carriage, under the back panel cover. To reach the fuses, remove the cover first.
  • Page 87 9 Installation 1. Detach two screws holding the cable router on the rear of the column. 2. Detach two screws holding the wall bracket rail cover in place. 3. Pull the rail cover off of the column. 4. Guide the bottom part of the rail cover through the additional wall bracket holder. 5.

  • Page 88: Exhibition Stand Installation

    9 Installation 8. Re-install the wall bracket rail cover back in place. 9. Re-install the cable clamp to its place. 10. Continue to install the column normally according to chapter Installing the device. 9.9.5 Exhibition stand installation If the device cannot be bolted to the floor, it may be installed on a special exhibition stand (ordered separately).
  • Page 89 9 Installation 2. Remove the tubehead front cover by detaching 4 screws holding the cover on the tubehead frame and pull it outwards. 3. To move the collimator in UP/DOWN direction, turn the collimator height adjustment screw: a) Clockwise to move the collimator downwards. b) Counter clockwise to move the collimator upwards.

  • Page 90: Sensor Adjustment

    9 Installation 9.9.7 Sensor adjustment If the device geometry calibration has failed due to the sensor being too high/low the height adjustment is needed. NOTICE! This adjustment is required only in special cases. 1. Pull the left and right sensor collar cover halves downwards. 2.

  • Page 91: Patient Positioning Light Adjustment

    9 Installation 6. Loosen the two (2) vertical screws. 7. Turn the adjustment screw to adjust the height of the sensor. One turn is equivalent of 0.7 mm. 8. Re-tighten the vertical screws after the adjustment. 9. Re-attach all covers in reverse order. 9.9.8 Patient positioning light adjustment If the positioning lights are aligned improperly, adjustment is needed to ensure correct patient positioning.
  • Page 92 9 Installation 2. The positioning lights are held in place in a fixture with one screw. Loosen the screw to release the light. Horizontal lights Midsagittal light 3. Re-align the light by rotating it and tilting it up/down. 4. Tighten the screw. 5.

  • Page 93: Device Configuration

    9 Installation Tilt light 1. Detach the Layer laser cover from the lower shelf by detaching a screw on the underside and pulling it out. 2. If you need to rotate the light, loosen the screw A. If you need to reposition the light assembly, loosen the screw B and move the assembly sideways by turning the screw 3.
  • Page 94 9 Installation 3. Select Preferences menu that appears under the Service menu. User configurable options: Configurations Friendly name Set a name for the device, which is shown next to the settings icon and on the imaging software. 3D Metal Artefact Enable or disable MAR, Metal Artefact Reduction Reduction.
  • Page 95 9 Installation Configurations for service personnel: Calibration Change the required calibration and QC Configurations intervals interval for the User and for Service (full calibration) according to the local regulations. The device will remind the user when re-calibration and new PAN QC and 3D QC retakes are required according to this setting.

  • Page 96: Verification

    9 Installation 9.9.10 Verification The device offers Panoramic and 3D verification test programs with the device movements disabled. These programs can be used for radiation related measurements, for example, during device installation and acceptance tests. A separate radiation measuring device/equipment is required for taking the radiation measurements.
  • Page 97 9 Installation 4. Select Drive to packing position. NOTICE! The device supports driving to Packing position in cases of Z- movement failure. 5. Press and hold down the exposure switch to drive the unit to the correct height. 6. Power the device off. 7.

  • Page 98: Technical Data

    10 Technical data 10 Technical data 10.1 Technical specifications General information Manufacturer: PaloDEx Group Oy, Nahkelantie 160, FI– 04300 Tuusula, FINLAND Quality system In accordance with ISO13485 standard Environmental management system In accordance with ISO14001 standard Conformity to standards: IEC60601–1 (ed.3)+Am1 IEC60601–1–3: (ed.2)+Am1 IEC60601–1–6 (ed.3.1) IEC60601–1–9 (ed.1)
  • Page 99 10 Technical data Device data Model: PCX–1 Protection against electric shock Class I Degree of protection Type B applied with no conductive connection to the patient Protection against the ingress of liquids IP20 Cleaning methods • Distilled water • Ethanol 96% •...
  • Page 100 10 Technical data Electrical connections Nominal mains voltage 100–240 Vac Input power frequency 50 / 60 Hz Nominal current 10A @ 220–240 VAC, 15A @ 100 – 120 Main fuses (F1 & F2) 220–240Vac: Littelfuse 215 (Time–Lag) 10A Cooper Bussman (Time Delay) S505H–10– 100–120Vac: Littelfuse 326 (SlowBlow) 15A Cooper Bussman (Time Delay) MDA–15...
  • Page 101 10 Technical data X–ray generator Generator High frequency DC generator Nominal power 1520 W nominal @ 95 kV, 16 mA Max. electric output 1,7 kW Anode voltage 60 – 95 kV (+/– 5 kV) Anode current 2 – 16 mA (+/– 20%) Exposure time accuracy +/–...

  • Page 102: Imaging Program Specifications

    10 Technical data Device package Package dimensions (L x W x H) 1200 x 770 x 1100 mm 47.2" x 30.3" x 43.3" Package weight 160 kg / 353 lbs Package material weight Pallet: 17 kg / 37.5 lbs Plywood: 14 kg / 30.9 lbs Cardboard: 12 kg / 26.5 lbs Ambient temperatures Transportation and storage...
  • Page 103 10 Technical data Scout programs & technical factors NOTICE! Tube voltage is fixed to 95 kV FOV size Resolution Pixel size mA range Exposure DAP range time 5 x 5 Scout 200 μm 4.0 - 12.5 0.04 - 0.03 s 4 - 9 mGycm 6 x 9 Scout...

  • Page 104: Patient Contacting Parts

    10 Technical data NOTICE! Device's radiation dose production vary from unit to unit. Radiation dose production, shown on the GUI, is calculated by scaling a measured reference dose production value with the selected imaging program technical factors and DAP correction factor described in chapter Device configuration.

  • Page 105: Device Dimensions

    10 Technical data 10.4 Device dimensions 765 mm / 30.1 in 1095 mm / 43.1 in 340 mm / 13.4 in 400 ± 20 mm 15.7 ± 0.8 in 320 ± 20 mm 12.6 ± 0.8 in 16 mm 20 mm 0.6 in 0.8 in A= 0.05m...
  • Page 106 10 Technical data PERPENDICULAR INSTALLATION ** 566 mm / 22.3 in 340 mm * 550 mm / 21.7 in 13.4 in * 1100 mm / 43.3 in ** 660 mm / 26 in ** 1375 mm / 54 in * Absolute minimum dimensions ** Recommended minimum dimensions INSTALLATION IN MAX 15°...
  • Page 107 10 Technical data INSTALLATION IN 15-40° ANGLE (RIGHT) ** 1032 mm / 41 in 54 mm / 2 in ** 1292 mm / 51 in NOTICE! This installation setup may require the carriage plywood supports to be removed before lifting the carriage on the column, as they might hit the wall. * Absolute minimum dimensions ** Recommended minimum dimensions WALL BRACKET DIMENSIONS...

  • Page 108: Symbols That May Appear On The Device Or Its Parts

    10 Technical data 10.5 Symbols that may appear on the device or its parts Manufacturer Date of manufacture Serial number Catalog or model number Caution Radiation warning Laser warning Radiation emitting device Type B Applied part Dangerous voltage On or enabled Off or disabled External warning light Exposure switch...
  • Page 109 10 Technical data Operating instructions Refer to operating instructions for more information. The operating instructions can be supplied electronically or in paper format. Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately.

  • Page 110: Electromagnetic Compatibility (Emc) Tables

    10 Technical data 10.6 Electromagnetic Compatibility (EMC) tables NOTICE! Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to EMC information. IEC60601-1-2 ed4 testing has verified that electromagnetic interference stimulus has no effect to safety critical functionality of the device. This includes the patient positioning and other imaging pre-conditions, imaging program value selection from the GUI, imaging process, image transfer to the workstation and the image quality.
  • Page 111 10 Technical data Table 2: Electromagnetic immunity IEC 60601-1-2 Ed4 PCX-1 is suitable for use in the specified electromagnetic environment. The purchaser or user of PCX-1 should assure that it is used in an electromagnetic environment as described below: Immunity Test IEC60601-1-2 Electromagnetic Environment Compliance Level...
  • Page 112 10 Technical data Table 3: RF immunity of non-life-support equipment or system IEC 60601-1-2 ed.4 PCX-1 issuitable for use in the specified electromagnetic environment. The purchaser or user of PCX-1 should assure that it is used in an electromagnetic environment as described below: Immunity Test IEC 60601-1-2 Compliance...
  • Page 113 10 Technical data Table 4: Separation distances Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601-1-2 The PCX-1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer of the user of PCX-1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PCX-1 as recommended below, according to the maximum output power of the communications equipment.

  • Page 114: X-Ray Tube Assemblies

    10 Technical data Interference may occur in the vicinity of equipment marked with the following symbol: WARNING! *** Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12") to any part of the device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 115 10 Technical data ™ ORTHOPANTOMOGRAPH OP 3D...

  • Page 116: Minimum Workstation Requirements

    8 GB Only validated GPU’s and WHQL certified driver versions may be used. GPU requirements and driver versions are dependent on the KaVo Driver version installed. Example of supported GPU's: • NVIDIA GTX 1050 Ti with 4GB memory • NVIDIA Quadro M2000 with 4GB...
  • Page 117 216453-2 Headquarters PaloDEx Group Oy | Nahkelantie 160 | P.O. Box 20 FI-04301 Tuusula | FINLAND | Tel. +358 10 270 2000 http://www.kavo.com/en/contact www.kavokerr.com Instrumentarium Dental | 11727 Fruehauf Drive | Charlotte, NC 28273 | U.S.A Tel. 800-558-6120 | Fax. 877-292-6050...

Table of Contents